BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II®

    MDR report key: 8950106 · Received August 30, 2019

    Report

    Report Number
    8950106
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    July 12, 2019
    Report Date
    July 24, 2019
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VALVULOPLASTY BALLOON WAS INFLATED AND THEN BURST. IT IS BELIEVED THAT THE BALLOON RUPTURED DUE TO THE HEAVY CALCIUM ON THE PATIENT'S VALVE WHICH POKED A HOLE IN THE PLASTIC OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746028 TYSHAK II® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT B. BRAUN INTERVENTIONAL SYSTEMS, INC 611929 TT-13460

    Patients

    Seq Age Sex Outcome Treatment
    1 32850 DA